Actively Recruiting
Study of CHS-114 in Participants With Advanced Solid Tumors
Led by Coherus Oncology, Inc. · Updated on 2026-03-19
87
Participants Needed
16
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.
CONDITIONS
Official Title
Study of CHS-114 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- For Arm 1a, participants have locally advanced or metastatic (Stage IV) solid tumors that progressed after standard therapy with no appropriate available treatments.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Lesions treated previously with radiation or local therapy must show progression to be target lesions.
- For Arms 1a, 1b, and 2, a washout period from prior anticancer therapy of more than 5 half-lives or 21 days, whichever is shorter.
- Resolution of non-immune-related adverse events from prior therapy to Grade 1 or less, and complete resolution of immune-related adverse events from prior checkpoint inhibitors.
- Serum creatinine clearance of at least 30 mL/min by Cockcroft-Gault formula.
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), or up to 3 times ULN if due to liver metastases or Gilbert's syndrome.
- AST and ALT less than 2.5 times ULN or less than 5 times ULN if liver metastases are present.
- Adequate blood counts: neutrophils ≥1.0 x 10^9/L, hemoglobin ≥8.0 g/dL, platelets ≥75 x 10^9/L.
- ECOG performance status of 0 or 1.
- Cardiac ejection fraction at least 50% by echocardiogram or equivalent.
- Willingness to use acceptable birth control methods during treatment and specified periods after last doses.
- For Arms 1b and 2, confirmed advanced or metastatic head and neck squamous cell carcinoma (HNSCC) progressed after platinum-based chemotherapy or PD-1/PD-L1 therapy.
- Metastatic or locoregionally recurrent HNSCC not curable by surgery or radiotherapy.
- For Arm 1b, accessible tumor tissue for biopsies and willingness to undergo them.
- For Arm 3, confirmed locally advanced or metastatic HNSCC excluding nasopharynx.
- Prior anti-PD-1/PD-L1 systemic therapy with progressive disease.
- Consent to provide HPV status and tumor tissue samples.
You will not qualify if you...
- Prior treatment with anti-CCR8 antibody or targeted therapy.
- History of severe allergic or anaphylactic reaction to monoclonal antibodies or their components.
- Major surgery within 4 weeks before screening.
- Unstable or severe uncontrolled medical conditions including unstable heart or lung disease, uncontrolled diabetes, or symptomatic fistula.
- For Arms 1b and 2, more than 4 prior systemic treatments for advanced/metastatic disease.
- Nasopharyngeal carcinoma or other nasal cavity malignancies besides HNSCC.
- Use of chronic anticoagulation therapy that cannot be safely stopped for biopsies.
- For Arm 3, two or more prior systemic treatments for advanced/metastatic disease.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
2
FOMAT Medical Research
Oxnard, California, United States, 93030
Actively Recruiting
3
Stanford Cancer Center
Palo Alto, California, United States, 94305
Actively Recruiting
4
SCRI Lake Nona DDU (FL Cancer Specialists)
Orlando, Florida, United States, 32827
Actively Recruiting
5
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
Hope & Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
7
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
8
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
9
University of Michigan
Ann Arbor, Michigan, United States, 48104
Actively Recruiting
10
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
12
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
13
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
START- San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
15
START Mountain
West Valley City, Utah, United States, 84119
Actively Recruiting
16
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Clinical Operations Team
CONTACT
M
MD at Coherus, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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